FDA cyber mandates for medical devices goes into effect

New regulations from the Food and Drug Administration (FDA) that went into effect on Sunday require vendors of medical devices to enhance security features in a bid to prevent hacking. The rules empower the FDA to refuse devices that do not meet its cybersecurity guidelines, and compel manufacturers to monitor and swiftly address known vulnerabilities. The regulations highlight the Biden administration’s push for stringent cybersecurity rules amid a surge in ransomware attacks on the healthcare sector.